Medical Drug Criteria (MDC)  

Policy Num:      P1.002.006
Policy Name:    Simponi ARIA® (golimumab)
Policy ID:          [P1.002.006]  [Ac / Mg / M+ / P+]  [0.00.00]

Last Review:       December 17, 2024
Next Review:       December 20, 2025
 

Related Policies: None

Simponi ARIA® (golimumab)

Summary

Golimumab is in a class of drugs called biologics.  Golimumab is a treatment for adults with moderate to severe rheumatoid arthritis, active psoriatic arthritis, or active ankylosing spondylitis. It is injected under the skin to reduce signs and symptoms of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, such as joint swelling, pain, fatigue, and length of morning stiffness.  Golimumab is commonly known as Simponi®. It can also be given as an infusion.

Policy Statements

Coverage is provided in the following conditions:

• Patient is at least 18 years of age, unless otherwise specified; AND

Universal Criteria ¹

• Patient has been evaluated and screened for the presence of latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring for presence of TB during treatment; AND
• Patient does not have an active infection, including clinically important localized infections; AND
• Patient will not receive live vaccines during therapy; AND
• Patient is not on concurrent treatment with another TNF inhibitor, biologic response modifier or other non-biologic agent (i.e., apremilast, tofacitinib, baricitinib); AND

Rheumatoid Arthritis (RA) ^1-4,9-11,17

• Must be prescribed by, or in consultation with, a specialist in rheumatology; AND
• Documented moderate to severe active disease; AND
• Patient has had at least a 3 month trial and failed of previous therapy with ONE oral disease modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, auranofin, hydroxychloroquine, penicillamine, sulfasalazine, leflunomide, etc.; AND
• Prescribed in combination with methotrexate unless contraindicated

Psoriatic Arthritis (PsA) ^5,6,8,18

• Patient is at least 2 years of age; AND
• Must be prescribed by, or in consultation with, a specialist in dermatology or rheumatology; AND
• Documented moderate to severe active disease; AND
  • For patients with predominantly axial disease OR active enthesitis, a trial and failure of at least a 4 week trial of ONE non-steroidal anti-inflammatory agents (NSAIDs), unless use is contraindicated; OR
  • For patients with peripheral arthritis or dactylitis, a trial and failure of at least a 3 month trial of ONE oral disease-modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, sulfasalazine, or hydroxychloroquine

Ankylosing Spondylitis (AS) ^7,12,19

• Must be prescribed by, or in consultation with, a specialist in rheumatology; AND
• Documented active disease; AND
• Patient had an adequate trial and failure of at least TWO (2) non-steroidal anti-inflammatory agents (NSAIDs) over 4 weeks (in total), unless use is contraindicated

Polyarticular Juvenile Idiopathic Arthritis (pJIA) ¹⁴

• Patient is at least 2 years of age; AND
• Documented moderate to severe active polyarticular disease; AND
• May be used alone or in combination with methotrexate; AND
• Patient has had at least a 1-month trial and failure (unless contraindicated or intolerant) of previous therapy with either oral non-steroidal anti-inflammatory drugs (NSAIDs) OR an oral disease-modifying anti-rheumatic agent (DMARD) (e.g., methotrexate, leflunomide, sulfasalazine, etc.)

Policy Guidelines

Renewal Criteria ¹

Coverage can be renewed based upon the following criteria:

• Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: serious infections, cardiotoxicity/heart failure, malignancy, demyelinating disorders, lupus-like syndrome, severe hypersensitivity reactions, severe hematologic cytopenias (e.g., pancytopenia, leukopenia, neutropenia, thrombocytopenia), etc.; AND

Rheumatoid Arthritis ^9-11

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts, reduction of C-reactive protein, improvement of patient global assessment, and/or an improvement on a disease activity scoring tool [e.g. an improvement on a composite scoring index such as Disease Activity Score-28 (DAS28) of 1.2 points or more or a ≥20% improvement on the American College of Rheumatology-20 (ACR20) criteria].

Psoriatic Arthritis ⁸

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts and/or an improvement on a disease activity scoring tool [e.g. defined as an improvement in at least 2 of the 4 Psoriatic Arthritis Response Criteria (PsARC), 1 of which must be joint tenderness or swelling score, with no worsening in any of the 4 criteria].

Ankylosing Spondylitis ⁷

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as total back pain, physical function, morning stiffness, and/or an improvement on a disease activity scoring tool [e.g. ≥ 1.1 improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS) or an improvement of ≥ 2 on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)].

Polyarticular Juvenile Idiopathic Arthritis (pJIA) ^15,16

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts, reduction of C-reactive protein, improvement of patient global assessment, and/or an improvement on a disease activity scoring tool [e.g., an improvement on a composite scoring index such as Juvenile Arthritis Disease Activity Score (JADAS) or the American College of Rheumatology (ACR) Pediatric (ACR-Pedi 30) of at least 30% improvement from baseline in three of six variables].

DOSAGE/ADMINISTRATION

Rheumatoid Arthritis/Ankylosing Spondylitis

• Administer a 2 mg/kg intravenous infusion at weeks 0 and 4, then every 8 weeks thereafter.

Psoriatic Arthritis

Adult:

• Administer a 2 mg/kg intravenous infusion at weeks 0 and 4, then every 8 weeks thereafter.

Pediatric:

• Administer an 80 mg/m2 intravenous infusion at weeks 0 and 4, and every 8 weeks thereafter.

Polyarticular Juvenile Idiopathic Arthritis (pJIA)

• Administer an 80 mg/m2 intravenous infusion at weeks 0 and 4, and every 8 weeks thereafter.

REQUIRED MEDICAL INFORMATION

• Patient has been evaluated and screened for the presence hepatitis B virus (HBV) prior to initiating treatment; AND
• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND

EXCLUSION CRITERIA

None

BENEFIT APPLICATION

As stated in the policy.

OTHER CRITERIA

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

References

1. Simponi ARIA [package insert]. Horsham, PA; Janssen Biotech Inc; February 2021. Accessed July 2021.
2. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2015 Nov 6. doi: 10.1002/acr.22783.
3. Weinblatt ME, Bingham CO 3rd, Mendelsohn AM, et al. Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial. Ann Rheum Dis. 2013 Mar;72(3):381-9. doi: 10.1136/annrheumdis-2012-201411. Epub 2012 Jun 1.
4. Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017 Mar 6. pii: annrheumdis-2016-210715.
5. Gottlieb A, Korman NJ, Gordon KB, Feldman SR, Lebwohl M, Koo JY, Van Voorhees AS, Elmets CA, Leonardi CL, Beutner KR, Bhushan R, Menter A. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol 2008 May; 58(5):851-64.
6. Ramiro S, Smolen JS, Landewé R, et al. Pharmacological treatment of psoriatic arthritis: a systematic literature review for the 2015 update of the EULAR recommendations for the management of psoriatic arthritis. Ann Rheum Dis 2016;75:490-498 doi:10.1136/annrheumdis-2015-208466
7. Van Der Heijde D, Ramiro S, Landewe R, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis doi:10.1136/annrheumdis-2016-210770

8. National Institute for Health and Care Excellence. NICE 2017. Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs.Published 24 May 2017. Technology Appraisal Guidance [TA445]. https://www.nice.org.uk/guidance/TA445/chapter/1-Recommendations. Accessed August 2017.
9. National Institute for Health and Care Excellence. NICE 2009. Rheumatoid Arthritis in Adults: Management. Published 25 February 2009. Clinical Guideline [CG79]. https://www.nice.org.uk/guidance/cg79/resources/rheumatoid-arthritis-in-adults-management-pdf-975636823525.
10. National Institute for Health and Care Excellence. NICE 2010. Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after failure of a TNF inhibitor. Published 10 October 2012. Clinical Guideline [TA195]. https://www.nice.org.uk/guidance/ta195/resources/adalimumab-etanercept-infliximab-rituximab-and-abatacept-for-the-treatment-of-rheumatoid-arthritis-after-the-failure-of-a-tnf-inhibitor-pdf-82598558287813.
11. Ward MM, Guthri LC, Alba MI. Rheumatoid Arthritis Response Criteria And Patient-Reported Improvement in Arthritis Activity: Is an ACR20 Response Meaningful to Patients”. Arthritis Rheumatol. 2014 Sep; 66(9): 2339–2343. doi: 10.1002/art.38705
12. Ward M, Deodhar A, Gensler L, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. 2019 Aug; Arthritis Care Res. doi: 10.1002/acr.24025.
13. Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018 Mar;14(3):e130-e136.
14. Ringold S, Angeles‐Han ST, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non-Systemic Polyarthritis, Sacroiliitis, and Enthesitis. Arthritis Care & Research, Vol. 71, No. 6, June 2019, pp 717–734 DOI 10.1002/acr.23870.
15. Ringold S, Bittner R, Neggi T, et al. Performance of rheumatoid arthritis disease activity measures and juvenile arthritis disease activity scores in polyarticular-course juvenile idiopathic arthritis: Analysis of their ability to classify the American College of Rheumatology pediatric measures of response and the preliminary criteria for flare and inactive disease. Arthritis Care Res (Hoboken). 2010 Aug;62(8):1095-102.
16. Consolaro A, Giancane G, Schiappapietra B, et al. Clinical outcome measures in juvenile idiopathic arthritis. Pediatric Rheumatology 18 April 2016 14:23.
17. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2021 Jun 8. doi: 10.1002/acr.24596.

18. Gossec L, Baraliakos X, Kerschbaumer A, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis. 2020 Jun;79(6):700-712. doi: 10.1136/annrheumdis-2020-217159.
19. Ward MM, Deodhar A, Gensler LS, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2019 Oct;71(10):1599-1613. doi: 10.1002/art.41042.

Codes

Applicable Modifiers

Some modifiers.

Policy History